Needle Mounting System And A Method For Mounting A Needle Assembly

ABSTRACT

A needle mounting system and methods for mounting a needle assembly on a needle mount are disclosed. The needle mounting system includes a needle hub having protrusions extending radially inward. A needle mount has a plurality of slots to receive the protrusions. The slots have a first portion that defines a passageway substantially parallel to a longitudinal axis of the needle mount and a second portion substantially perpendicular to the axis. The needle hub and mount provide a method wherein a needle assembly may be mounted on an injection device without completely rotating the needle hub relative to the needle mount.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of Ser. No. 11/778,274,filed on Jul. 16, 2007, which is a divisional application of Ser. No.10/609,744 filed on Jun. 30, 2003 which claims priority under 35 U.S.C.119 of Danish application no. PA 2002 01169 filed Aug. 1, 2002, and U.S.provisional application No. 60/394,083 filed Jul. 3, 2002, the contentsof which are fully incorporated herein by reference.

THE TECHNICAL FIELD OF THE INVENTION

The present invention relates generally to injection devices and, inparticular, provides methods and systems for mounting a needle to aninjection device or to an ampoule that my be mounted in the injectiondevice.

DESCRIPTION OF RELATED ART

Injection devices, also referred to as dosers, have greatly improved thelives of patients who must self-adminster drugs and biological agents.Dosers may take many forms, including simple disposable devices that arelittle more than an ampoule with an injection means or they may behighly sophisticated instruments with numerous functions. Regardless oftheir form, they have proven to be great aids in assisting patients toself-adminster injectable drugs and biological agents. They also greatlyassist care givers in administering injectable medicines to thoseincapable of performing self-injections.

In particular, pen-style injection devices, have proven to be anaccurate, convenient, and often discrete, way to administer drugs andbiological agents, such as insulin. Modern devices have become moresophisticated and often include diverse and robust functions, such asmemories for remembering time and amount of last dose, as well as, inthe case of insulin devices, blood glucose monitors. While pen-styledosers are typically cylindrically shaped with needles protruding fromthe most distal portion of one end of the device, some of the moremodern and/or sophisticated dosers have other shapes with the needle nolonger protruding from the most distal part of an end of the device.(See e.g., Innovo® and InnoLet® from Novo Nordisk A/S BagsvaerdDenmark).

Typically, injection devices use a pre-filled cartridge containing themedication of interest. The cartridge may be an integral part of thedoser or it may comprise an ampoule having a membrane at one. See U.S.Pat. No. 6,312,413 to Jensen et. al, which is hereby incorporated byreference. Often the end of the ampoule having the membrane is fittedwith a needle mount. The needle mount usually comprises a threadedmounting surface to allow a needle assembly, such as a needle and hubassembly, to be screwed on.

The needle mount may be an integral part of the ampoule or may be aseparate adapter top (see U.S. Pat. Nos. 5,693,027 and 6,126,646, whichare hereby incorporated by reference) that is mounted to the ampoule. Ofcourse, some dosers have needle mounts that are integral parts of thedoser.

In the typical injection device where the needle mount is not part ofthe doser, the end of the ampoule having the needle mount protrudes fromthe injection device. Where the needle mount is part of the doser, theneedle mount is usually disposed on an outer end of the doser. In eitherembodiment, the needle hub is then screwed onto the needle mount. Onedisadvantage of the prior art needle mounting systems is that theyrequire the patient to screw the needle hub onto the end of the ampoule,or the doser, by turning the needle relative to the device severaltimes. For patients with dexterity problems, this is inconvenient.Moreover, it is often desirable to store needles for the injectiondevices in a magazine. Often many newer generation injection devices arenot cylindrical and in many new devices, other parts of the deviceextend past the needle mount making it impossible to mount the needle onthe injection device without first removing it from the magazine.

SUMMARY OF THE INVENTION

The present invention provides systems and methods for mounting needleassemblies to injection devices and/or ampoules. In some, but notnecessarily all embodiments, the system and method of the presentinvention allows a needle and hub assembly to be mounted on an ampouleand/or injection device without having to rotate completely the needlehub assembly relative to the injection device. In one embodiment of thepresent invention, a needle assembly is comprised of a needle mounted ina hub. The needle assembly also includes a means for mounting the hub toa needle mount with only a partial rotation of the needle hub relativeto the mount. In an other embodiment of the present invention, a needlemount for mounting the needle assembly is comprised of an outer wall anda mounting means for affixing the needle assembly to a top end of theouter wall. In some embodiments, the means provides for completelysecuring the needle assembly to the needle mount with only a partialrotation of the needle mount. In some embodiments, the needle mountincludes a means for aligning the needle assembly on the mounting means.The needle mount and needle assemblies of the present invention, whencombined, make up a needle mounting system. The system, or itscomponents, may also include a means for tactilely or audiblydetermining when the needle assembly is securely mounted on the needlemount.

At least one embodiment of the present invention includes a needleassembly that is comprised of a needle mounted to a hub having aninterior wall. In this embodiment, a plurality of protrusions extendsradially inward from the wall of the hub. Typically, the hub wall iscylindrical. A needle mount for use with the present invention, may inat least one embodiment, include a structure having a cylindrical outerwall. A plurality of grooves is disposed on the outer wall. The groovesbegin at the top of the wall and contain at least two portions: a firstportion that defines a passageway that is substantially parallel to thecylindrical axis of the outer wall, and a second portion that isoriented at an angle to the first portion. Of course, the presentinvention may be embodied in structures wherein the grooves are disposedinside the hub of the needle mount and the protrusions are disposed onan outer surface of the needle mount.

In at least one embodiment of the present invention, the needle assemblyis completely mounted on an injection device with only a partialrotation of the needle assembly relative to the injection device. (Thoseskilled in the art will recognize that rotation of the needle assemblyrelative to the injection device may be accomplished by holding thedevice stationary and rotating the needle assembly or by holding theneedle assembly stationary and rotating the device or by a combinationof these steps). In some embodiments, the needle is mounted on anampoule that is mounted in the injection device.

The present invention therefore provides a method for mounting needlesto injection devices. The method may be useful in mounting needlesstored in magazines and is particularly useful for injection devicesthat have a portion that extends past the needle mount. In oneembodiment, the injection device is partially inserted into a magazineholding needle assemblies. The injection device is rotated relative tothe magazine by less than a full revolution and is then removed with theneedle assembly attached thereto. In some embodiments no or minimalrotation is required.

In other embodiments of the present invention, the needle assembly mayinclude a cylindrical hub that has a needle mounted thereon. The hub mayhave an internal cylindrical element with an outside cylindrical wallthat faces the hub's inside cylindrical wall. A plurality of protrusionsmay extend radially outward from the internal cylindrical element. Acorresponding needle mount may be used. The needle mount, in oneembodiment, may include a plurality of locking elements arranged on aninterior cylindrical surface (e.g., a wall) of the needle mount to formfirst passageways that are substantially parallel to the cylindricalaxis of the needle hub. In some embodiments, the locking elements aredisposed on a ring that is part of the interior surface or that isattached to, or part of, an inside wall of the needle mount.

Further the protrusions could be sized to fit between threads of astandard ampoule adapter top. The protrusions arranged on the inner hubwall and aligned between the threads of a standard adapter top wouldallow the needle assembly to be screwed onto the adapter top in atraditional manner.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a three-dimensional view of a needle hub and needle mountaccording to one embodiment of the present invention.

FIG. 2 is a cut-away view of the needle mount and needle hub shown inFIG. 1.

FIG. 3 is a three-dimensional view of a needle assembly and needle mountaccording to a second embodiment of the present invention.

FIG. 4 illustrates the embodiment of FIG. 3 when viewed from below.

FIG. 5 is a cut-way view of the needle assembly of FIGS. 3-4.

FIG. 6 is an enlarged view of the needle assembly mounting means of theembodiment shown in FIGS. 3-5.

FIG. 7 is a cut through view of the needle mount and needle hubillustrating one embodiment of the present invention for tacitlydetermining whether the needle hub is securely mounted on the needlemount.

FIG. 8 is a side view of a magazine for storing needles that may be usedin practicing the method steps of the present invention.

FIG. 9 is a top view of the magazine shown in FIG. 8.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides for systems and methods for attachingneedle hub assemblies to ampoules and injection devices. Typically, aneedle hub assembly comprises a needle 510 mounted to a hub 500 (seee.g. FIG. 3). As is shown in FIG. 1, a needle hub 10 may be generallycylindrically shaped and have an interior wall surface 20. In oneembodiment of the present invention, a plurality of protrusions 30extends radially inward from the interior surface 20.

A needle mount 100 is designed to accept the needle hub 10. (See e.g.FIG. 1). As is shown in FIGS. 1 and 2, the needle mount 100 may begenerally cylindrically shaped and have an exterior wall surface 110. Aplurality of grooves or slots 120 are disposed in the exterior surface110. The grooves 120 have a first end 122 and a second end 125. Thegrooves 120 have a first portion 130 that defines a passageway that isgenerally parallel to the cylindrical axis 1000 of the needle mount 100.While the first portion of the groove 130 is shown in the drawings ashaving a rectangular portion, the exact shape of the groove is notcritical so long as it allows the protrusions 30 on the needle hub tomove in a direction parallel to the cylindrical axis 1000. Thus, whilethe groove may have walls that are not necessarily parallel to thecylindrical axis 1000, the groove may still be said to be parallel tothe cylindrical axis if it allows the protrusions 30 to move in adirection parallel to the cylindrical axis. The first portion of thegrooves 130 may have width that is wider than the remainder of the firstportion or the remainder of the groove 130. In embodiments where thegroove has walls that are not parallel to the cylindrical axis 1000, thewidth of the first portion of the groove 130 may be the average widthfor the first portion of the groove 130.

The first portion 130 may have an entrance 135 that has a widthdimension that is greater than the average width of the first portion oris wider than the average width of the entire groove 120. The entrance135 may act as an alignment means for aligning the needle hub so thatthe protrusions will enter the groove 120. In most embodiments, but notall, the entrance width is wider than any other point in the groove 120.Typically the width of the groove narrows as the groove is traversedaway from the entrance 135. As is shown, the groove may reach a constantwidth at some distance from the opening. In some embodiments the widthof the first portion 130 is widest at the entrance 135 and continues tonarrow over the length of the first portion 130. The grooves also have asecond portion 150 that is either perpendicular to the cylindrical axis1000, or lies at angle to the first portion 130. In some embodiments ofthe present invention the second portion 150 may be comprised of onlyone surface that is generally perpendicular to the cylindrical axis ofthe needle mount. Thus, the second portion of the groove 150 need not bea slot having two sides, but needs only one side to prevent protrusionson the needle hub from moving toward the outer end of the needle mount.As shown in FIG. 1, the grooves 120 may also have a third portion 160that is oriented at an angle to the first portion 130 and the secondportion 150.

In some embodiments of the present invention a means for tacitlydetermining whether the needle assembly is securely fixed to the hub isprovided. This may be accomplished in numerous different ways, includingproviding a small projection(s) 439 at the side or in the bottom of thesecond portion of the grooves 120. (See e.g. FIG. 7). The protrusions 30have to overcome the projections 439 before the needle is fixed. Thedeformation of the projections may cause a tacitly feel or a sound, suchas a clicking sound. Thus, in some embodiments of the present invention,the needle mounting system can be designed so that the needle hub andthe needle mount generate a clicking sound when the needle is securelyplaced on the mount. When the hub is to be remounted from injectiondevice the oblique tactile protrusions can be more sharp at their ends,so that hub is better fixed during injection and handling etc. This alsomakes it possible for the patient to keep the needle for more injection.

One advantage of the present invention is that the needle mount, may beequipped with standard threads 200 on its exterior surface. (See FIG.1). The grooves 120 may be cut into the standard threads 200. Thisallows the needle mount 100 to accept not only needle hubs of thepresent invention, but also standard, threaded needle-hub assemblies.

While FIG. 1 shows the grooves on the needle mount and the protrusionson the needle hub, the present invention may be configured with thegrooves located on the interior surface of the needle hub and theprotrusions extending outward from the exterior wall of the needlemount. In some, embodiments it may be advantageous to size and shape theprotrusions so that they fit between standard threads used with existingneedle hubs. The protrusions may then be arranged on the exterior wallof the needle mount to allow not only needle hub assemblies havinggrooves in their interior wall to be attached, but also standard,threaded needle hubs.

The present invention may take numerous other forms, including—but notlimited to—that shown in FIGS. 3-6. As is shown in FIGS. 3-6. the needlehub assembly 500 has a needle 510 mounted thereto. The needle hub 550may be generally cylindrically shaped and has an interior wall surface600 and a closed top end 610. The closed top end 610 has an insidesurface 620. A cylindrical member 650 protrudes from the inside surface620 and has an outer surface 660. See FIG. 5. Protrusions 670 extendradially outward from the outer surface 660. The protrusions may takevarious forms and shapes, including the triangular prism shape shown inthe drawings.

The needle hub assembly shown in FIGS. 3-5 may be used with a modifiedneedle mount, 700. As is shown in FIGS. 3-6, the needle mount 700 may begenerally cylindrically shaped and have a top end, an interior surface,an exterior surface, and a plurality of locking elements (which may beadditional protrusions) extending from the interior surface inward. Thelocking elements may be arranged to form passageways for the protrusions500 on the needle mount, thereby forming a plurality of grooves foraccepting the protrusions from the needle hub assembly 500. As is shownin FIG. 6, the grooves may have a first portion 561 that defines apassageway that is generally parallel to the cylindrical axis of theneedle mount, a second portion 571 that is perpendicular to thecylindrical axis and a third portion 588 that connects the second 571and first portions 561. The first portion 561 may be widest at itsopening and thus act as an alignment mechanism for the protrusions onthe needle hub. The needle mount may have a mounting surface 581 onwhich a portion of the needle hub rests when the needle hub is mountedon the needle mount. The mounting surface may be a top edge of the topend of needle mount, or it may be the exterior wall surface 599 of theneedle mount or both. The embodiment shown in FIGS. 2-4 alsoadvantageously allows the outer surface of the needle mount to havethreads so that standard prior-art needle hubs may be used with theimproved needle mount of the present invention.

The present invention enables various methods for attaching a needle-hubassembly to an ampoule or injection device. For example, in oneembodiment of the present invention, a needle mount is inserted into aneedle hub, the needle hub is rotate relative to the needle mount lessthan one revolution—typically between 5 and 30 to 60 degrees. In someembodiments, a clicking noise or vibration or other tactile feedbackwill be provided to indicate that the needle is securely mounted to thehub. In some embodiments little rotation is necessary. In someembodiments, it is possible that no rotation is needed. The surface ofthe locking element 777 could simply force the hub to rotate uponinsertion of the mount into the interior of the hub 500. In otherembodiments, more rotation may be required.

Because the methods of mounting a needle hub to a needle mount do notrequire that the hub be rotated a full revolution relative to the mount(i.e. either the hub is rotated and the mount is held stationary or themount is rotated and the hub is held stationary, or both are turned inopposite direction), the present invention enables and provides formethods of mounting needle-hub assemblies stored in magazines, similarto that shown in FIGS. 8 and 9, to injection devices where their shapewould not allow the device to be rotated relative to the magazine by afull revolution. In one embodiment of the present invention, a portionof an injection device 3000, usually the portion containing a needlemount 3010, is inserted into a needle magazine 3050. The device 3000,without being rotated a full revolution is then removed with a needlefully attached to it. In some embodiments audible or tactile feedback isprovided to indicate that the need is securely mounted to the device. Insome embodiments, the portion of the device that is inserted into themagazine may be an end portion of an ampoule that extends from thedevice. Some methods of practicing the present invention may beperformed using the needles are stored in a magazine having a flushsurface 3070 and the needle and hub assemblies 3080 are located belowthe surface 3070, usually—but not necessarily—in recessed cavities 3090(see FIG. 9).

The foregoing is a brief description of some exemplary embodiments ofthe present invention and is intended to be illustrative and notexhaustive of the present invention. Those of skill in the art willrecognize the nature of language makes it impossible to capture theessence of all aspects of the present invention and unimportant andinsubstantial substitutes for various elements are intended to beincluded within the scope of the invention as defined by the followingclaims.

1. A mounting system for mounting two different needle arrangements, themounting system comprising: a threaded surface for threadedly couplingand threadedly mounting a needle assembly, and a surface comprisingL-shaped grooves for receiving a bayonet coupling on a medical device,thereby allowing the needle mount to fixedly attach to either a threadedassembly or a bayonet assembly.
 2. The mounting system of claim 1wherein the needle mount is incorporated into an adapter.
 3. A needleassembly comprising: a needle; and a hub that is attached to the needle,the hub comprising: an inner cylindrical hub wall; and a plurality ofprotrusions extending radially inward from the hub wall wherein a partof the needle is located inside the boundaries of the interiorcylindrical wall, wherein a part of the needle is located inside theboundaries of the inner cylindrical wall.
 4. The needle assemblyaccording to claim 3, wherein the protrusions comprises a circularsurface.
 5. The needle assembly according to claim 3, wherein theprotrusions extends perpendicular to a cylindrical axis.
 6. The needleassembly according to claim 3, wherein the protrusions are located inthe proximity of a proximal end of the hub opposite the top end.
 7. Theneedle assembly according to claim 3, wherein the protrusions are sizedto fit between threads of a standard ampoule adapter top and wherein theprotrusions are arranged on the inner hub wall to align between thethreads of the standard adapter top, thereby allowing the needleassembly to be screwed onto the adapter top.
 8. The needle assembly ofclaim 7, wherein the protrusions are sized to fit between standardinsulin needle assemblies.
 9. A method for mounting a needle assembly toa needle mount, the method comprising: i) inserting the needle mountinto an interior hub of a needle assembly comprising: a needle; and ahub that is attached to the needle, the hub comprising: an innercylindrical hub wall; a plurality of protrusions extending radiallyinward from the hub wall wherein a part of the needle is located insidethe boundaries of the inner cylindrical wall, wherein the protrusions ofthe hub engage grooves of the needle mount, and wherein part of theneedle in the needle assembly is located within the boundaries of theinner cylindrical wall enters into the needle mount following thecylindrical axis, and ii) partially rotating the needle mount and theneedle assembly relative to each other.
 10. The method for mounting aneedle assembly according to claim 9, wherein the needle mount and theneedle assembly are rotated less than one revolution relative to eachother.
 11. The method for mounting a needle assembly according to claim10, wherein the needle mount and the needle assembly are rotated between5 and 60 degrees relative to each other.
 12. The method for mounting aneedle assembly according to claim 9, wherein the needle mount and theneedle assembly are rotated between 5 and 30 degrees relative to eachother.
 13. A method of providing a user with a plurality of ways toattach a needle assembly to a medication containing apparatus having aneedle mount, the method comprising: supplying a needle mount on themedication containing apparatus, supplying a first threaded needleassembly that mounts on the needle mount, and supplying a secondnon-threaded needle assembly that attaches to the needle with an axialand rotation movement wherein the rotational movement is less than 360degrees.
 14. The method of claim 13 wherein the second non-threadedneedle is secured via bayonet action.
 15. A mount system for attachingto a distal end of an injection device a bayonet style connector inwhich a double point needle is disposed within a cylindrically shapedtubular element comprising an inner cylindrical wall from which one ormore protrusions extend radially inward and a conventional a pen needlesecured to conventional pen needle hub that comprises an inner surfacefor engaging a male thread mount disposed on an injection device, themount system comprising: a cylindrical wall on which the bayonetconnector may be attached, the wall containing one or more grooveshaving a first longitudinal part and second part oriented at an angle tothe first the system further comprising a male thread disposed on anouter surface at the distal end of the device the thread beingcomplimentary to the female thread on the inner wall of the hub of theconventional needle thereby allowing a bayonet connection to be attachedto the device and removed with less than a 90 degree rotation and thenallowing a conventional needle hub to be secured and then removed byunscrewing the conventional needle from the device.
 16. A mount systemfor attaching two different needle systems to an injection device havinga distal, injecting end portion, one needle system being a conventionalpen needle comprised of a hub in which a needle is disposed and whereinthe hub contains an inner wall having an inner cylindrical call adaptedfor being screwed onto or off of a male thread so as to allow the hub toscrewed on to the injection device at the distal end, the second needlesystem being a double pointed needle disposed within a tubularcylindrical element having a inner cylindrical wall and having innerradially extending protrusions that form a portion of a bayonetconnector, the mount system comprising: a first coupling comprised of amale thread disposed on the distal end portion with a male threadadapted for receiving the conventional pen needle, and a second couplingcomprised of cylindrical wall having a plurality of grooves having alongitudinal portion and a second portion extending at an angle from thelongitudinal portion, grooves adapted to receive the tubular element andsecure it to the device with only a partial rotation thereby allowingthe injection device to have the conventional needle mounted after thebayonet connector is mounted and removed.